Tirzepatide in Obesity-Driven Endometrial Cancer
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUNC Lineberger Comprehensive Cancer Center
About this trial
LCCC2415 examines the antiproliferative effect of tirzepatide on the endometrium of endometrial cancer (EC). This is a pre-operative window clinical study. Endometrial biopsy samples from patients before tirzepatide treatment will be compared to their post-intervention hysterectomy specimens. If archival tissue is unavailable, a fresh biopsy will be taken before tirzepatide treatment. Post-intervention tissue will be collected from the hysterectomy specimen.
The hypothesis is that tirzepatide's anti-tumorigenic effects are due to both an improvement in the host's metabolic milieu (indirect effect) and a direct effect on the EC tumor microenvironment via the inter-related pathways of insulin, lipid, and mTOR signaling. Therefore, tirzepatide may be an innovative approach to effectively induce weight loss and inhibit tumor growth in EC, the most obesity-driven of all cancers.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Current diagnosis of endometrioid histology cancer and scheduled to undergo hysterectomy and staging.
Agree to comply with all required study assessments and visits including internet capabilities.
Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
Age ≥ 18 at the time of consent.
Disqualifiers
Active infection requiring systemic therapy.
Subject is pregnant or breast feeding.
Taking any prescription medications or other drugs that may influence metabolism per discretion of investigator.
Taking a central nervous system stimulant.
Trial design
Design model
Single group
Treatments tested in this trial
Tirzepatide
DrugTirzepatide will be administered once weekly, subcutaneously, and patients will be taught how to administer this drug at home. Patients will be started on a dose of 5 mg tirzepatide weekly for four weeks prior to surgical staging. .
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: endometrial carcinomaExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Proliferation
Change in Proliferation will be determined by immunohistochemical ( Ki-67 staining) analysis pre- (baseline) and post-tirzepatide treatment hysterectomy samples (at the time of surgery and end of treatment). The percentage of tumor cells that are positive for Ki-67, indicating they are in the active phases of the cell cycle (not resting). Low Ki-67 (\<10-15%): Slower-growing tumor. Intermediate (15-30%): Moderately proliferative. High (\>30%): Fast-growing, potentially more aggressive.
Time frame
Baseline - Up to 6 weeksSecondary outcomes
1
Improvement in Diabetes
Diabetes status (yes/no) will be documented before and after tirzepatide treatment using the medical records and diabetes diagnostic criteria.
Time frame
Baseline - Up to 6 weeks2
Improvement in HgbA1C level
HgbA1C level will be documented pre- and post-tirzepatide treatment.
Time frame
Baseline - Up to 6 weeks3
Improvement in waist-to-hip ratio
The waist-to-hip ratio will be documented pre- and post-tirzepatide treatment.
Time frame
Baseline - Up to 6 weeks4
Improvement in Body Mass Index
Body Mass Index (measured by dividing weight in kgs by height in meters) will be documented pre- and post-tirzepatide treatment.
Time frame
Baseline - Up to 6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
UNC Lineberger Comprehensive Cancer Center
Lead sponsor
United States Department of Defense
Collaborator
Source ClinicalTrials.gov